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Instructor : John E Lincoln
Product Id : 30993PACK

Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective and/or preventive actions (CAPA), and do proper impact analysis / actions. Such failure investigation and root cause analysis is a major element of cGMP compliance. If inadequately performed it is also a key source of regulatory problems. How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? How can line operators' brains be engaged by the use of such simple yet powerful tools? Use the templates, tools and methodology presented in this webinar to facilitate a closed-loop problem resolution system to reduce "fire fighting" and minimize compliance problems.

Why you should attend: Expectations for meaningful CAPA, supported by results-driven Failure Investigation and Root Cause Analysis, that addresses and resolves underlying product problems, are growing among regulatory agencies world-wide. EU's ISO 14971 (Device Risk Management) and the FDA's QSIT (devices) and ICH Q9 (drugs), underscore this increased emphasis. A valid closed-loop CAPA system requires defined failure investigation including systemic root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that such effective and repeatable failure investigation and root cause analysis is still not the industry norm.

The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop failure investigation / root cause analysis as an integral part of CAPA, Validation and Quality Management Systems / cGMP planning, implementation and execution.

Areas Covered in the Session:

  • Regulatory "Hot Buttons"
  • The 4 Basic Steps to Problem Solving
  • A Suggested Investigation Template
  • ID / Document the Problem - CAPA, et al
  • Failure Investigation / Analysis Methodology - And One Possible Template
  • Use the 7 Tools to Find the Solution(s)
  • Monitor for Effectiveness
  • Lock In the Change - Close the Loop
  • Take It to the Next Level

Who Will Benefit:
  • Senior management in Drugs, Devices, Biologics, Dietary Supplements
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
  • Consultants; others tasked with product, process, CAPA resolution, failure investigation responsibilities

Instructor : Betty Lane
Product Id : 30993PACK

Overview: In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. There will be a review of the principles of Corrective and Preventive Action. Risk Management is a current FDA hot topic, and Root cause analysis and Risk Management are intimately connected, and using risk management principles while doing root cause analysis is not only smart but cost effective.

We will also cover where else in your quality management system root-cause analysis can be used. Learn how Root cause analysis can be used in process control. We will describe and give examples of some of the techniques for doing and effective root cause analysis. You will learn about various techniques that are available so you can choose the one or ones that fit your situation.

Why should you Attend: Is your Corrective action system effective or do the same or similar problems keep occurring? If so you may not be doing root cause analysis in sufficient depth. Corrective and Preventive actions (CAPA) are key to an effective quality management system. Corrective and Preventive Action is one area where the FDA continually finds problems in quality systems. And if you do not do an effective Root Cause you will not have a good corrective action system and will find that problems will reoccur, and are likely to lead to increasingly more serious problems.

Areas Covered in the Session:
  • What is Root Cause
  • The difference between Correction, Corrective Action and Preventive Action
  • Why Root Cause Analysis is important
  • Where Root cause Analysis is valuable
    • Corrective and Preventive Action
    • Risk Management
    • Process Control
  • Several techniques for doing Root Cause Analysis
  • Relationship between Root Cause and Risk Management
  • Looking other places in the QMS where Root Cause Analysis is valuable

Who Will Benefit:
  • Quality Managers and Directors
  • Quality Engineers
  • Manufacturing Engineers
  • Internal auditors
  • Quality specialists
  • Quality Associates
  • Operations and Manufacturing Managers
  • Process Engineers

Betty Lane has over 30 years' experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Betty's training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Device - Quality Management Systems - System Requirements for regulatory purposes, and FDA Quality System Regulation - Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.

Instructor : Susanne Manz
Product Id : 30993PACK

Overview: This webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you. We will discuss requirements, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls.

We'll discuss best practices so you can start off on the right foot and always be prepared for an inspection.

Why should you Attend: CAPA is the corner stone of an effective Quality Management System. Yet, it frequently perceived as a burdensome and bureaucratic exercise. Many companies struggle to establish and maintain a CAPA program that is efficient and effective. An ineffective CAPA System leads to disastrous consequences such as medical device reports, recalls, 483s, and warning letters. And an inefficient CAPA program results in wasted time, money, and missed opportunities. In this webinar, we’ll discuss the fundamentals of a CAPA program and how you can make your CAPA program more efficient and more effective.

Areas Covered in the Session:
  • FDA and NB expectations for CAPA
  • Lessons Learned from 483s and warning letters
  • Common problems and simple solutions
  • How to structure your CAPA process
  • How to use IT tools to monitor and maintain your CAPAs
  • Metrics to ensure your CAPAs are timely and effective
  • A toolkit for CAPA

Learning Objectives
  • Overview of the Regulations
  • FDA Expectations
  • Lessons Learned and Common Mistakes
  • Best Practices
  • Preparing for an FDA Inspection

Who Will Benefit:
  • Quality Systems Specialists
  • Document Control Specialists
  • Quality and Compliance Specialists
  • Internal Auditors and Managers
  • Training Specialists
  • CAPA Specialists
  • Supplier Quality Engineers and Auditors
  • Quality/Compliance Managers or Directors for Medical Device companies
  • General Managers wanting to learn how to understand Quality System requirements

Instructor : Jeff Kasoff
Product Id : 30993PACK

Overview: Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.

Areas Covered in the Session:
  • Documents Used by FDA Inspectors
  • Investigations Operations Manual (IOM)
    • CAPA Implications
    • Recommended Methods of Compliance for each Requirement
  • CPG Manual 7382.845
    • CAPA Implications
    • Recommended Methods of Compliance for each Requirement
  • QSIT Manual
    • Description of each CAPA Inspectional Objective
    • Recommended Methods of Compliance

Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device,
Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
  • QA management
  • CAPA coordinator
  • Regulatory Affairs management
  • Executive management
  • Consultants
  • Quality System Auditors

Instructor : David R Dills
Product Id : 30993PACK

Overview: CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.

Industry is now using various risk-based approaches and tools to set-up, deploy and maintain their CAPA programs to help with the decision making process. Understand the emphasis on analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems...and the use of appropriate statistical methodology where necessary to detect recurring quality problems.

This session provides an overview on identifying recommended practices to improve, streamline, refine, retool…and develop, deploy and maintain a viable and sustainable CAPA system. Learn that a well written policy and procedure on setting up and maintaining your system is just the first part of the process…now you need to monitor your system because CAPA is your immune system and will determine how healthy or unhealthy or business site is. Learn some of the new practices being used on how to conduct the CAPA investigation and the use these tools.

Areas Covered in the Session:
  • How to use FMEA effectively and calculating Risk Priority Numbers: How to Use the Criteria
  • How to facilitate a product complaint investigation as part of your CAPA program
  • What is a closed-loop investigation…cradle to grave approach
  • How to conduct an investigation using a well-written CAPA policy and procedure
  • Understand and comprehend what FDA is looking for in meeting minimum expectations…no band-aid solutions
  • Why risk assessment and risk-based approaches, FMEA, FTA, HACCP, etc., are now the expectation in terms of good business practice
  • Establish a priority system as related to major versus minor or high risk versus low risk classifications…to support your decisions
  • Develop and deploy escalation rules and criteria to facilitate decision-making process
  • Understand what it takes to conduct a “quality” investigation to ascertain the root cause
  • Review and discuss recent CAPA red flags and FDA enforcement actions

Who Will Benefit:This webinar will provide valuable assistance and guidance to all regulated companies that are preparing to use or are currently using risk-based tools for CAPA investigations and closing out investigations in a timely manner. The employees who will benefit include:
  • All levels of Management for all departments and those who desire a better understanding or a "refresh" overview
  • QA/QC/CAPA Coordinators/CAPA Specialists
  • Regulatory Affairs and Compliance
  • Engineering/Technical Services/Operations
  • Consultants

David R. Dills, is Director of Regulatory Services at CROMSOURCE, an international contract research organization (CRO) to the pharmaceutical, biotechnology, and medical device industries. Mr. Dills has more than 28 years of experience in the medical device and pharmaceutical industry. He has held positions of increasing responsibility with sponsor and service companies of various sizes, including large, global OEM’s/sponsors, consultancies and a global CRO, as well as virtual, small, mid and large-sized enterprises and has serviced sponsors and clients in multiple global locations. Mr. Dills’ most recent position was President and Principal, Global Regulatory Affairs Consultant with a consultancy in the US, and prior to that he served in senior level regulatory and compliance roles for various organizations.

He has a range of expertise in different therapeutic areas and medical specialties for pharma and medical devices, including combination products. David enjoys interpreting the regulatory precedents and new legislation, developing the regulatory strategy as part of strategic regulatory consulting, Agency meeting preparation and engagement, conducting persuasive communication with regulatory authorities, executing an effective path to approval for submissions and marketing applications with multi-country registrations and approvals, developing GxP compliance strategies from premarketing to postmarketing from R&D, Manufacturing/Operations, Postmarket and to delivering regulatory and compliance training to internal and external stakeholders, and striving for overall corporate compliance with regulations in The Americas, EMEA and Asia Pacific.

He has managed regulatory and compliance projects with multiple competing priorities having a direct impact on site operations commercial opportunities and enjoys adding business value to clients by providing strategic and tactical solutions that facilitate the achievement of regulatory and compliance milestones and on minimizing delays due to noncompliance and regulatory risk. He has worked directly with global manufacturers and sponsors engaged in compliance remediation activities and services involving enforcement actions and customer generated compliance events, inspection preparation, among other regulatory and compliance responsibilities.

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